NCT01336738

Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Conditions

• Diabetes, Type 2

Interventions

Type	Name	Description
DRUG	Placebo	Tablets (n=6), 0 mg, once daily for 84 days
DRUG	150 mg PF-04991532	Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
DRUG	450 mg PF-04991532	Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
DRUG	750 mg PF-04991532	Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
DRUG	Sitagliptin 100 mg	Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-04-18
• Last updated: 2013-08-06
• Results posted: 2013-08-06

Locations

44 sites across 7 countries: United States, Canada, Hungary, Mexico, Slovakia, South Korea, Taiwan